SUMMARY PI: Freedman, David Scott Institution: nanoView Diagnostics Inc. Pancreatic cancer is the fourth leading cause of cancer death in the US and is estimated to become the second leading cause of cancer deaths in the US by 2020. The high mortality rate is a direct result of early clinical diagnosis being difficult because initial symptoms of the disease are often nonspecific. If pancreatic cancer is detected early, the average five-year relative survival rate increases 11-fold. Tools to detect the disease at the early stage are needed to improve outcomes. There are no clinically validated biomarkers for early detection of pancreatic cancer but studies have shown that exosomes can serve as a perfect blood- based test that and that this biomarker has the potential to be used for pancreatic cancer screening. Despite the identification of this powerful biomarker, tools to translate this test into a scalable workflow are still lacking. nanoView Diagnostics (NVDX) has developed an optical sensing technique that can enumerate these circulating biomarkers directly from sample. The NVDX platform is capable of detecting many different targets from a small volume of blood using a simple workflow and inexpensive consumables. NVDX will establish that a pancreatic test can achieve high sensitivity and specificity in a relatively large number of early-stage pancreatic cancer samples and also demonstrate that the assay is reproducible across a number of sensor manufacturing runs. The second aim test the developed assay with blinded samples to detect early-stage pancreatic cancer and results will be compared to clinical diagnosis. Completion of the phase I work will position NVDX to pursue clinical validation of the exosome based PDAC assay. In a phase II proposal, NVDX will establish standard operating procedures for the assay for user independent performance. The automated NVDX platform will be tested with 300 patients to validate performance and demonstrate clinical utility. The success of the SBIR research would enable nanoView Diagnostics to run multi-center clinical trials for commercialization of a pancreatic screening test.